Select Clinical Trials in Pancreatic CancerStatus for all Trials, September 2010: Open for EnrollmentPhase III TrialsOfficial TitleA Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the PancreasPrimary EndpointOverall Survival (OS)SponsorAbraxis BioScience Inc.Study ChairDaniel Von Hoff, MDContact InformationAmanda Johnson; tel: 919-433-8449; e-mail: ajohnson@abraxisbio.comClinicaltrials.gov IDNCT00844649; study start: 2009Official TitleRT0G-0848:APhase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients With Resected Head of Pancreas AdenocarcinomaPrimary EndpointOSSponsorRadiation Therapy Oncology GroupStudy ChairRoss A. Abrams, MDContact InformationTel: 269-373-7458Clinicaltrials.gov IDNCT01013649; study start: 2009Official TitleNLG0405: A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without HyperAcute®-Pancreatic Cancer Vaccine in Subjects With Surgically Resected Pancreatic CancerPrimary EndpointOSSponsorNewLink Genetics CorporationStudy DirectorNicholas N. Vahanian, M.DContact InformationNewLink Genetics Corporation: 515-296-5555Clinicaltrials.gov IDNCT01072981; study start: April 2010Phase II TrialsOfficial TitleAC0S0G-Z5041 : A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic AdenocarcinomaPrimary EndpointOS at 2 yearsSponsorAmerican College of SurgeonsStudy DirectorPeter W.T Pisters, MDContact InformationPeter W.T Pisters; tel: 713-792-3245Clinicaltrials.gov IDNCT00733746; study start: 2009Official TitleA Phase 1 /Randomized Phase 2 Study to Evaluate LY2603618 in Combination With Gemcitabine in Patients With Pancreatic CancerPrimary EndpointPhase I: Determine the maximum tolerated dose for LY2603618 when administered after gemcitabine; phase II: OSSponsorEli Lilly and CompanyStudy ChairNot listed (see contact information)Contact InformationTel: 1-877-CTULLY (1-877-285-4559)Clinicaltrials.gov IDNCT00839332; study start: 2009Locally Advanced, UnresectableOfficial TitleTH-CR-404: A Randomized Cross-over Phase 2 Study of the Safety and Efficacy of Two Dose Levels of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Locally Advanced Unresectable or Metastatic Pancreatic AdenocarcinomaPrimary EndpointProgression-free survival (PFS)SponsorThreshold PharmaceuticalsPrincipal InvestigatorsMitesh Borad, MD; Shantan Reddy, MDContact InformationClarence Eng, MPH; Ph: 650-474-8222; e-mail: ceng@thresholdpharm.comClinicaltrials.gov IDNCT01144455; study start: June 2010Metastatlc, UntreatedOfficial TitleA Phase 1 b/2 Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic CancerPrimary EndpointsSafety profile including MTD; OSSponsorInfinity PharmaceuticalsResponsible PartyInfinity Pharmaceuticals (Shannon Devens)Contact InformationJulie Martin, Ph: 864-455-3667; e-mail: jmartin@ghs.orgClinicaltrials.gov IDNCT01130142; study start: April 2010First-line, UnresectableOfficial TitleC0-101-001:APhase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic AdenocarcinomaPrimary EndpointOverall survival in patients with low hENT1 expressionSponsorClovis Oncology, Inc.Responsible PartyClovis Oncology, Inc. (Lindsey Rolfe, MD)Contact InformationEmail: clinicaltrialinfo@clovisoncology.comClinicaltrials.gov IDNCT01124786; study start: May 2010Multitumor, AdvancedOfficial TitleIPI-926-03: A Phase II, Open Label, Non Randomised, Non Comparative, Multicentre Study to Assess the Efficacy and Safety of Olaparib Given Orally Twice Daily in Patients With Advanced Cancers Who Have a Confirmed Genetic BRCA1 and/or BRCA2 MutationPrimary EndpointTumor ResponseSponsorAstraZenecaStudy DirectorJames Carmichael, BSc, MBCHB, MD, FRCPContact InformationPh: 877-400-4656; e-mail: astrazeneca@emergingmed.comClinicaltrials.gov IDNCT01078662; study start: February 2010New Phase III International TrialsOfficial Title0XAL0_L_04918: A Randomized Phase III Study of Capecitabine or 5-Fluorouracil-based Regimen With or Without Oxaliplatin as 2nd Line Treatment of Advanced Pancreatic Cancer in Patients Who Have Previously Received Gemcitabine-based ChemotherapyPrimary EndpointPFSSponsorSanofi-AventisStudy DirectorMedical Affairs, Sanofi-AventisContact InformationE-mail: publicregistrygma@sanofi-aventis.comClinicaltrials.gov IDNCT01121848; study start: June 2010